Following positive epidemiologic studies, statins to enter clinical trials for cancer prevention.

1172 NEWS Journal of the National Cancer Institute, Vol. 97, No. 16, August 17, 2005 Statins grabbed the headlines earlier this year when several epidemiologic studies produced promising results that the cholesterol-lowering drugs might be associated with reduced risks of several cancers, including breast, colorectal, lung, and prostate cancers. Although some researchers have called for large randomized trials to assess statins’ anticancer effects, the drugs will receive their fi rst tests in two smaller phase II trials set to begin later this year. The fi rst study to receive attention was presented at the annual meeting of the American Association for Cancer Research in April. Using data from the Health Professionals Follow-up Study, Elizabeth Platz, Sc.D., from the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues found that the use of cholesterol-lowering drugs, mostly statins, was associated with a 46% relative reduction in the risk of advanced prostate cancer and a 66% reduction in the risk of metastatic or fatal disease, although there was no association with total risk of the cancer. The following month, at the American Society of Clinical Oncology annual meeting, three studies presented that were based on prescription records from the Veterans Administration found that statin use was associated with a 51% relative reduction in the risk of breast cancer, a 54% reduction in the risk of prostate cancer, and a 48% reduction in the risk of lung cancer. The same group presented two more studies based on the VA database at the 2005 Digestive Disease Week the same month that found statin use to be associated with reductions in the risk of esophageal and pancreatic cancers (56% and 59% relative reductions, respectively). The most recent study came in the May 26 issue of the New England Journal of Medicine . Stephen B. Gruber, M.D., Ph.D., an associate professor at the University of Michigan Comprehensive Cancer Center in Ann Arbor, and his colleagues reported the results of a case – control study of nearly 4,000 people from northern Israel. They found that 5 or more years of statin use, both self-reported and confi rmed through prescription records, was associated with a 47% relative reduction in the risk of colorectal cancer. If this relative reduction were proved true, the authors determined that statin use could prevent 20.8 cases of colorectal cancer per 100,000 Jewish men treated. “ The encouraging fi nding was that this protective association was unique to that class of drugs, ” Gruber said. Other types of cholesterol-lowering drugs were not associated with cancer risk. And perhaps even more surprising was that the association was as strong as that found with nonsteroidal anti-infl ammatory drugs (NSAIDs), a class of drugs already shown to have chemopreventive potential in colorectal cancer, Gruber said. In less than two decades since the fi rst statin was approved, statins — also known as 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors — have become one of the most widely prescribed types of drugs available in the United States. In 2000, more than 76 million prescriptions for statins were fi lled, and up to one-third of the population may be taking the drugs for dyslipidemia (high cholesterol) and the prevention of coronary heart disease. “ Statins are so interesting, obviously, because so many people are taking statins, ” said Ernest Hawk, M.D., Following Positive Epidemiologic Studies, Statins to Enter Clinical Trials for Cancer Prevention